drugset / Trial / NCT06189157

MB-CART19.1 in Refractory SLE

NCT06189157

Phase 1/2 Recruiting 29 enrolled Miltenyi Biomedicine GmbH
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels. In the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.

Timeline

Start
2024-08-12
Primary completion
2027-09-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-CD19 CAR-T cells Cell therapy 100000 cells
Subject anti-CD19 CAR-T cells Cell therapy 500000 cells
Subject anti-CD19 CAR-T cells Cell therapy 1e+06 cells